510(k) Report

510(k) · Cleared

Cleared

Equitest

K851744510(k) TraditionalCleared Aug 5, 198598-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neurocom International, Inc. · LXV Apparatus, Vestibular Analysis

Cleared on Aug 5, 1985 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 5, 1985
Review
98 days
Class
Class U
Product code
LXV
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK851744 EquitestNeurocom International, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK971549 VMT SystemTarget Health, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K971549VMT SystemTarget Health, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851744EquitestNeurocom International, Inc.1985—
+1K971549VMT SystemTarget Health, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K851744, 1985–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LXV device

  1. #1 K220231 GyroStimscore 3.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971549VMT SystemTarget Health, Inc.19980

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971549 (Target Health, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LXV devices

LXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXV

1in 2022

2007: 22008: 22009: 12010: 12012: 12018: 12019: 22020: 22022: 1
2007high 2 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXV

Too few LXV 510(k)s in any year since 2007 to give a median.

Recalls per year · LXV

1in 2009

2008: 12009: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LXV

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code LXV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20082—10
20091—10
20101—01
20110—00
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—00
20192—00
20202—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K851744: Equitest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851744

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026